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IASOcholine®

[18F] fluorocholine

Therapeutic indications

This medicinal product is for diagnostic use only.

Fluorocholine (18F) Chloride is indicated for use with Positron Emission tomography (PET).

IASOcholine is used for imaging in patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced choline influx of specific organs or tissues is the diagnostic target.

The following indications for PET with fluorocholine (18F) Chloride have been sufficiently documented:

Prostate cancer

Detection of bone metastases of prostate cancer in high risk patients.

Hepatocellular carcinoma

  • Localisation of lesions of proven well-differentiated hepatocellular carcinoma
  • In Addition to FDG PET, characterisation of liver nodes and/or “staging“ of proven or very likely hepatocellular carcinoma, when FDG PET is non conclusive or when surgery or grafting is scheduled

CLINICAL PARTICULARS

Approvals

Country Product Approval number Date of reg. PDF PDF
Austria IASOcholine 4-00044 25.08.2011 SPC PIL
Belgium de IASOcholine BE 440 176 (15mL) 08.07.2013 SPC PIL
Belgium de IASOcholine BE 440 185 (25mL) 08.07.2013 SPC PIL
Belgium fr IASOcholine BE 440 176 (15mL) 08.07.2013 SPC PIL
Belgium fr IASOcholine BE 440 185 (25mL) 08.07.2013 SPC PIL
Belgium nl IASOcholine BE 440 176 (15mL) 08.07.2013 SPC PIL
Belgium nl IASOcholine BE 440 185 (25mL) 08.07.2013 SPC PIL
Bulgaria IASOcholine II-19591/20.09.12 20.09.2012 SPC PIL
Czech Republic IASOcholine 88/651/12-C 14.11.2012 SPC PIL
Germany IASOcholine 81779.00.00 19.07.2011 SPC PIL
Estonia IASOcholine 792812 29.08.2012 SPC PIL
France IASOcholine 34009 578 253 3 1 (15mL) 02.04.2015 SPC PIL
France IASOcholine 34009 576 946 1 6 (25mL) 02.04.2015 SPC PIL
Luxembourg de IASOcholine 2013080285 01.08.2013 SPC PIL
Luxembourg fr IASOcholine 2013080285 01.08.2013 SPC PIL
Malta IASOcholine MA986/00101 26.04.2013 SPC PIL
Poland IASOcholine 20446 31.07.2012 SPC PIL
Romania IASOcholine 8391/2015/01-02 17.10.2012 SPC PIL
Slovenia IASOcholine H/12/00746/001 (15mL) 11.07.2012 SPC PIL
Slovenia IASOcholine H/12/00746/002 (25mL) 11.07.2012 SPC PIL
Slovak Republic IASOcholine 88/0527/12-S 05.12.2012 SPC PIL
Italy Pcolina 043096015 (13mL) 03.02.2014 SPC PIL
Italy Pcolina 043096027 (15mL) 03.02.2014 SPC PIL
Lithuania Pcolina LT/1/12/3159/001 (15mL) 17.12.2012 SPC PIL
Lithuania Pcolina LT/1/12/3159/002 (25mL) 17.12.2012 SPC PIL
english IASOcholine   04.2010 SPC PIL
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